BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTSWITCH 1895420 XPS MULTIFUNCTIONAL

    MDR report key: 2945223 · Received January 31, 2013

    Report

    Report Number
    1045254-2013-00057
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 23, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT DATE WAS NOT IDENTIFIED BY THE CUSTOMER. THE XPS 3000 SYSTEM IS INDICATED FOR USE IN ORTHOPEDIC SURGICAL PROCEDURES WHERE THE CUTTING AND REMOVAL OF SOFT AND HARD TISSUE OR BONE IS REQUIRED. THESE INCLUDE SPINAL AND SMALL AND LARGE JOINT ARTHROSCOPIC PROCEDURES. UPON RETURN OF THE DEVICE, BOTH VISUAL AND FUNCTIONAL TESTING COULD NOT DUPLICATE THE REPORTED DEVICE MALFUNCTION. HOWEVER, THERE ARE NON-DEVICE RELATED ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDING (BUT NOT LIMITED TO): USE OF UNAPPROVED COMPONENTS, MAIN GROUND FAILURE, ELECTRICAL GROUNDING WITHIN THE HANDPIECE OR CONSOLE, ETC.

    Description of Event or Problem · 1

    THE MFR HAS CHANGED/IMPROVED THE CRITERIA FOR MAKING MDR DECISIONS AND A RETROSPECTIVE REVIEW OF COMPLAINT FILES FOUND THE FOLLOWING EVENT: A SURGEON REPORTED THAT HE RECEIVED AN ELECTRIC SHOCK WHEN HE TOUCHED THE FOOTSWITCH USED WITH THE XPS MODEL 3000 SYSTEM. THE PRODUCT WAS RETURNED FOR EVAL, HOWEVER, THE REPORTED EVENT COULD NOT BE DUPLICATED; THE DEVICE FUNCTIONED AS INTENDED. ALTHOUGH THE EVENT COULD NOT BE DUPLICATED, A PRODUCT PROBLEM MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43105 FOOTSWITCH 1895420 XPS MULTIFUNCTIONAL ERL - DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1895420 59175700

    Patients

    Seq Age Sex Outcome Treatment
    1